drugset / Trial / NCT02460276
A Trial of Ibrutinib, Lenalidomide and Rituximab for Patients With Relapsed/Refractory Mantle Cell Lymphoma
Phase 2
Completed
50 enrolled
Lund University Hospital
Celgene Corporation · collabJanssen, LP · collabNordic Lymphoma Group · collab
NaSingle-groupOpen-labelTreatment
Summary
In this trial, patients with mantle cell lymphoma will be included, treatment with lenalidomide, rituximab and ibrutinib will be administered in an induction phase for up to 12 cycles, cycle length 28 days. Patients with complete remission, partial response or stable disease will enter a maintenance phase with treatment with ibrutinib and rituximab until progression of disease. The primary objective is to evaluate overall response rate, based on PET and CT.
Timeline
- Start
- 2015-04
- Primary completion
- 2019-12-31
- Completion
- 2019-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibrutinib | Small molecule | 560 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 15 mg | Oral |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 1400 mg | Intravenous |